Human hand mimetic and pediatric bolster support system device

ABSTRACT

A human hand mimetic and pediatric support system device to provide comfort, positioning aid, sense of security and support for infants, especially premature infants or other users lacking full mobility. This device consists of a cavity in the shape of a human hand (glove/mitten) partially or totally filled with a freely flowable material and closed at the cuff. An optional extension to the cuff mimics an arm/forearm to provide extra length, weight and/or flexibility of usage. This device provides continual gentle pressure and subtle restraint by mimicking the touch of a human hand and conforming to the contour of the body. The device may be used directly touching the skin, is washable without disassembly, and it does not interfere with medical or other equipment. It may be used under or over the body of the infant (excluding the face) or to secure external items in place such as pacifiers, bottles, paperwork, toys, tubes, etc.)

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] Not Applicable

STATEMENT REGARDING FED SPONSORED R&D

[0002] Not Applicable

REFERENCE TO SEQUENCE LISTING, A TABLE, OR A COMPUTER PROGRAM LISTING APPENDIX

[0003] Not Applicable

BACKGROUND OF THE INVENTION

[0004] This invention relates to a device to provide comfort, positioning aid, sense of security and support for infants, especially premature infants or other users lacking full mobility. It provides continual gentle pressure, aid in positioning, and subtle restraint by mimicking the shape/weight of a static human hand and providing an optional extension that may be converted to a pediatric bolster support system device.

[0005] The caregiver of premature and term infants must determine the position that is more comfortable for the infant given his/her specific situation and medical condition. At the present, there are a variety of devices that are currently used to assist on the comfort of infants:

[0006] Positional aids: Nurses use different elements to secure the position of the infant and/or the medical equipment and other items both touching the infant as well as away from him, i.e., they tape the items to a nearby blanket and/or to a small stuffed animals to secure the position of the medical equipment (i.e., tubes, cables, etc) and other devices (i.e., pacifiers, blankets, paperwork, etc.)

[0007] Support: Towels, blankets, cloth diapers and even t-shirts are rolled to give support and assist on positioning the infant while laying or sitting down. These devices are made out of cloth and they are soft and flexible thus they do not provide sufficient support, they also can unroll easily.

[0008] Sense of security: caregivers often “swaddle” infants in towels or blankets to give them some support and boundaries, in addition, some place light and small stuffed animals over the infants (on the chest or below and/or on the back of the head) when they cannot use their own hands to offer continual gentle pressure to their patients. However, these items do not conform to the body and may be too light defeating the purpose of its use. Currently, it is common to see 1 to 5 infants for each nurse and the nurses can not use their own hands to give constant support or restraint.

[0009] None of these devices above are made for the purpose mentioned; moreover, they do not conform to the infant's bodies and while not serving the purpose well, they may be unsafe by creating a suffocation hazard and also may interfere with hospital equipment such as tubes, cables, etc. Moreover, the items that are rolled (towels, t-shirts, etc) may unroll and not provide the support needed; and, the families of the infants, for the most part, must provide the stuffed animals, so not every infant has one to use for comfort.

[0010] The human hand mimetic and pediatric bolster support system device of this invention provides the intended use of all the devices mentioned above by assisting as:

[0011] Positional aid: by providing boundaries and the ability to use the device on top/under/around or away from the body when laying in any position or sitting up, or by assisting with positioning and securing external elements such as medical equipment (tubes, etc), blankets, pacifiers, etc.

[0012] It provides support by preventing rolling of the infant by applying pressure to any body part (except the face) while in prone position (i.e., on top of the back, legs, back of the head, etc, or under the stomach, etc.) or supine position (i.e., under the head, or under or on top of arms, legs, etc.) or sideling (i.e., on the back of the head, or on top of the hip, as back support, on or between the legs, etc.). The device also may include and extension to the cuff to simulate an arm/forearm to give extra support by increasing the volume and maintaining the density. In addition, this extension may be converted to be a pediatric bolster support system by shifting and securing the pellets to the extension's side and making its density 100%, that way, the extension becomes harder, less flexible and heavier, providing extra support to the infant. This device, when converted to the pediatric bolster system, may not be placed over the infant as it does not totally conform to the shape of the body and it may be too heavy for premature infants.

[0013] Sense of security: to the infant by placing it fully or partially over the body (except the face), giving the sense of being touched and accompanied. It conforms to the body and is sufficiently heavy to prevent slipping. It can be used safely in any environment, is convenient, practical, washable without disassembly, and it is inexpensive, giving the possibility to provide one device for each infant minimizing potential contamination due to sharing of devices among infants. It also gives a sense of comfort for the infant's family as the shape of the device is appealing and familiar to them by resembling their own hands that stay with the infant while they cannot be with him/her. At the end of the hospitalization, the family may take the device home with them and use it for support in the car seat during transportation.

[0014] Many products have been developed to assist infants, including U.S. Pat. No. 5,996,152 of Wilson (1999). In that patent, the sleep promoting and comforting device for infants uses clips that may not be suitable for premature infants in the Neonatal Intensive Care Unit (NICU) as many of the premature infants in incubators or warmers do not wear clothing. Moreover, the use of clams and rod-like structures and the device that covers a great deal of the infant's body may interfere with hospital equipment/devices such as warmers, IVs, tubes, etc. In addition, different sizes of the device must be made to fit the different infant sizes. A device that can be used not only for term newborn infants but for premature infants as well and one that does not require different parts that may malfunction or interfere with medical devices will be desirable.

[0015] Further, U.S. Pat. No. 6,161,239 of Grazel (2000), the infant positioning device must be made to fit the weight and height of the infant as the elongated sleeve is used to surround or wrap about the infant, therefore, different sizes of the device must be provided to fit infants of different sizes, i.e., for those weighing 2 pounds or less up to those weighing 7 lbs or more. Moreover, this device is not to be placed on top of the infant but surrounding him/her. It would be preferable that the same size device could be used on different size users and for its design to allow it to be placed on top, under, away and by the infant to provide flexibility of use and provide sense of security, aid in positioning, support and comfort.

[0016] Likewise, the following patents disclose devices that provide infant support and/or comfort: U.S. Pat. Nos. 4,538,310 (Scott, 1985), 4,783,865 (Stotler, 1988), 5,048,136 (Popitz, 1991), 5,014,376 (Doran et al), 5,272,780 (Clute, 1993), 5,375,278 (VanWinkle, 1994), 5,581,832 (Bridley, 1996), 5,499,418 (Tan, 1998), and 5,988,752 (Richards, 1999). None of these devices are used to be placed on top of the infant but below or besides him/her. Moreover, none of the devices in these patents may be used to combine comfort, positioning aid, support and a sense of security for the user.

BRIEF SUMMARY OF THE INVENTION

[0017] This invention is a device used to provide comfort, sense of security and support for infants and other users by mimicking a human hand and providing a pediatric bolster support system device. The invention comprises a cavity with the shape of a human hand (glove or mitten) and may also include an optional appendage or extension to the cuff to mimic a forearm/arm to form a pediatric bolster support system device to provide ease of positioning, extra weight or support. Both the hand and the extension may be partially or fully filled with a freely flowable material and may have the capacity to conform to the contour of the infant and provide adequate subtle and continuous pressure to mimic a human hand. It also gives a sense of comfort for the infant's family as the shape of the device is familiar as it mimics their own hands that stay with the infant while they cannot be with him/her.

[0018] The sack or cavity is made of a soft and fully washable material and may be safely placed directly on the infant's skin. Contained within the cavity is any free flowable material although it is recommended the use of pellets of a material such as polyethylene that is washable and inert to fluids, medicines, or other materials that may be spilled on the device.

[0019] It may be used under/over/by any part of the body excluding the face of the infant to prevent suffocation, and, while lying down in any position (prone, supine, and sideling) or sitting up. In hospitals and at home care, it can be used without interfering and even securing medical equipment such as tubes, and other equipment.

[0020] The device is washable without disassembly, and may also be used to secure external objects in place such as pacifiers, blankets, papers, toys, tubes, monitor probes, and other hospital or home devices by the weight of the device or using a tying mechanism found at the end of the device. The hand and/or the extension may contain internal or external apparatus such as a vibrator, warmer, rattle, music/message player, etc. In all hospital units, such as cancer units, intensive care units, and at any place, the device assists on giving the patients a sense of being touched and comforted by someone while they lack full mobility; moreover, the size of the user is unimportant.

[0021] Accordingly, several objects and advantages my HUMAN HAND MIMETIC AND PEDIATRIC BOLSTER SUPPORT SYSTEM DEVICE are:

[0022] 1. To provide a device that will provide continual gentle pressure and subtle restraint to the user by mimicking a human hand

[0023] 2. To promote rest and sleep to the user by soothing, providing boundaries and a sense of being accompanied.

[0024] 3. To assist on the comfort and safety of the premature infant child seat, strollers, etc., by placing it on the sides of the infant to prevent movement or shifting while restrained.

[0025] 4. To provide a device to be used in any place, including hospitals, daycares, car seats, at home, etc.

[0026] 5. To assist patients while they remain hospitalized or at home, without interfering with medical equipment.

[0027] 6. To provide a device that is safe, small, light weight, convenient, transportable, washable without disassembly, easy to use, that may be used directly on the skin and at the same time it is effective and affordable

[0028] 7. To provide a device that is affordable to hospitals, contributing organizations or individuals so each infant may be the owner of his/her own device and take it for use at home minimizing the risk of contamination by sharing.

[0029] 8. To give support and gentle pressure to the infant while performing activities such as massages, playing times, therapy, etc.

[0030] 9. To provide extra uses if it contains optional internal or external apparatus such as a vibrator, warmer, rattle, music/message player, etc.

[0031] 10. The ability to convert the device to a pediatric bolster support system device by shifting the filling to either side to increase the density volume to 100% and securing it with a tying mechanism. The density volume of the hand and forearm/extension sides of the device may be made heavier/lighter, hard/soft, and be used as a pediatric bolster support system device when the density volume is increased to 100%.

[0032] 11. To give the flexibility to be used on any lying position and over/under/away from the infant:

[0033] a. Under the infant—as a pillow, neck roll, leg support under the knee, to raise the head or body, between the legs while sideling, under the stomach while in prone position, etc.

[0034] b. Over the infant—mimicking a human hand touching back of the head while immobilized, over the hips, arms, legs, buttocks or other body part except the face. When the device is converted to a pediatric bolster support system device it is discouraged to use it over premature infants as it does not conform to the body and it may be too heavy.

[0035] c. By or around the infant—as back support to prevent roll-overs, as head support to prevent the child from moving it to the back, around the infant to provide boundaries, used to secure objects like pacifiers, etc.

[0036] d. Away from the infant—as a weight or securing other objects such as paperwork, blankets, or medical equipment like tubes, monitor probes, etc.

[0037] 12. To provide a comfort item to children that is safe and familiar to the user and caregivers

[0038] 13. To prevent/eliminate odors when filled partially with deodorizing pellets.

[0039] 14. To assist on aromatherapy if partially filled with scented pellets.

[0040] 15. To assist patients of any size that lack full mobility.

[0041] 16. The shape of the device resembles a human hand and it is appealing and familiar to the user, the caregiver and their families and may be made of different sizes

[0042] 17. Because of the flexible nature of the materials, the device will contour the surface where is placed on making the size of the user unimportant.

BRIEF DESCRIPTION OF THE DRAWINGS

[0043]FIG. 1 shows a perspective view of the human hand mimetic device of the present invention; Part 1 is the sack in shape of a hand, part 2 is the seam that shuts the cavity at the end of the device, and Part 3 a at the cuff is the optional piece of material that serves as a string that may be used to assist on securing external devices and/or hanging the device for storage

[0044]FIG. 2 shows part 1, 2 and 3 a of FIG. 1, and part 4 is the freely flowable material that is the content of the cavity. The device may be filled partially or fully.

[0045]FIG. 3 shows the hand shaped cavity (Part 1), the seam (Part 2), the tie mechanism (Part 3 a), the freely flowable material (Part 4) and Part 5 is the optional and permanent extension to the cuff that mimics the arm/forearm with an additional optional string (part 3 b) at the seam. This extension forms a pediatric bolster support system device as the volume density of either side (hand-part 1 or forearm-part 5) may be controlled by using part 3 a to tie it around the device at the cuff preventing the shifting of the pellets (part 4). Part 5 resembles a long cuff or sleeve.

[0046]FIG. 4 shows an infant with the pediatric bolster support system device of this invention being used while sideling. The string (part 3 a) is used to secure the increased volume density of the extension (part 5) to 100% to provide extra support. Note the “hand” (part 1) is almost empty of pellets (part 4) as they were shifted to the extension side and secured with part 3 a.

[0047]FIG. 5, shows the human hand mimetic device (part 1, 2 and 3 a) without the extension (part 5) placed on top of the child while sideling to give him continual gentle pressure and subtle restraint and boundaries. The device may also be used over or under any part of the body except the face (i.e., back of the head, back, legs, stomach, etc) while laying in any position or sitting up.

[0048]FIG. 6 shows an external object, this case a pacifier, being secured and positioned by pediatric bolster support system device. In this case, the string (part 3 a) at the cuff is used to secure the increase of the volume density of the extension (part 5) by decreasing it at the hand (part 1). As other option, the “fingers” of part 1 may also be used to assist with positioning when the volume density is increased in the hand side (part 1) of the device and decreasing it at the extension (part 5) side of the device and securing it by tying the string (Part 3 a) around the device. The optional string at the cuff (part 3 a) may also be used to secure external items.

DETAILED DESCRIPTION OF THE INVENTION

[0049]FIG. 1 shows a perspective of the human hand mimetic device (part 1) constructed in accordance with the present invention. As can be seen, the device resembles a human hand, where the part 1 is of the shape of a hand or glove. The recognizable shape of the hand provides a sense of comfort for the infant's relatives as it mimics their own hands that stay with the infant while they cannot be with him. It also mimics the weight and comforting touch of the hands of the caregiver.

[0050] The material is washable and may be in direct contact with the sensitive skin of the infant, such as a smooth 100% cotton or 100% polyester to prevent marking the skin of the infant. The seam (part 2) closes the cavity at the end of part 1; FIG. 1 shows it 2 cms from the end of the device. Part 3 a is the optional tying mechanism, for example a string-like that is used to assist on securing external devices or to store by hanging it. This string is made of 100% cotton or 100% polyester, a soft, washable material that allows easy tying/untying and the length 30 cms attached to the device at the middle of the string by the seam (part 2). The caregiver to ensure the safety of the child and prevent choking may shorten this length.

[0051] Now turning to FIG. 2, there is shown the flowable material (part 4), preferably a material such as pellets that is washable and inert to fluids, medicines, or other materials that may be spilled on the device. In addition, the material should provide sufficient weight to offer support and subtle restraint. It may comprise a polymeric plastic composition and in the preferred embodiment, the composition is of a high-density polyethylene (HDPE). Also, the pellets (part 4) may be smooth and spherical with about one-eighth to one-quarter of an inch of diameter. Other shapes may be used, yet, their size should be equivalent. It may also be filled partially with deodorizing pellets to prevent/eliminate odors, or with scented pellets to assist on aromatherapy and use in other environments.

[0052] Together with the type of material, the fill density of the cavity is important. The fill density and pliability are given by the amount of pellets inside the cavity. It should be filled so that the cavity is flexible, it gives enough support and restraint and can be used over an infant. That is, between 100 and 300 grams to resemble the human hand weight, or filled between 60% and 80% of the capacity of the cavity.

[0053]FIG. 3 shows the hand shaped cavity (Part 1), the seam (Part 2), the freely flowable material (Part 4) and Part 5 that is the optional extension that mimics the arm/forearm that may be converted into the pediatric bolster support system device. This extension provides the device with extra room for more pellets to provide more weight and more area of support by retaining the density and increasing the volume. If the extension (part 5) is used, the size recommended is 25 cm of length and 5 cm of diameter. The seam at the end of the extension may be a straight seam to make a flat end, as shown in part 2, or one that makes the end round or circular, square, rectangular, etc, to eliminate the edges of the flat end.

[0054] The weight of the device will increase but the density volume remains 60-80% of the total cavity. If the extension is made, an extra string (part 3 b) is provided. Both strings (part 3 a and 3 b) may be used to secure external items to the device or to hang the device for usage and/or storage. The string at the cuff (part 3 a) is also used to tie it around the cuff to secure the volume density of either side of the device according to the user's preferences and needs. As the density volume of one side (part 1 or part 5) increases by shifting the pellets (part 4), the other side is decreased. By increasing the density, that side of the device becomes heavier, fuller, less flexible and may be used as a bolster support system device for extra-support. By decreasing the density, the side becomes flatter, lighter and more flexible. The string at the cuff (part 3 a) is tied around the cuff to secure volume density of either side of the device (the hand/part 1 or the forearm extension/part 5). The device may be used under or over any part of the body excluding the face of the infant, and, while lying down in any position (prone, supine, and sideling).

[0055] Now turning to FIG. 4, it shows an infant in the sideling position with device converted to the pediatric bolster support system device of this invention. In this use, the extension (part 5) lies directly on the back of the infant providing support to avoid rolling over. The volume density of the forearm (extension—Part 5) is increased to 100% by shifting all the pellets to the forearm/extension section and tying the string (part 3 a) around the cuff to secure it. This allows the device to get heavier, decrease flexibility and provide extra support. In this case, the “hand” side (part 1) is almost empty of pellets. It is discouraged to use the device over a premature infant when it is converted to the pediatric bolster support system device, as it does not conform to the shape of the body and may be too heavy for the tiny infants creating a possible safety hazard.

[0056] In FIG. 5, the device is placed on the top of the child while sideling to provide comfort. In this figure, the device does not include the extension (part 5). In hospitals it can be used without interfering with medical equipment such as tubes, monitor probes, warmers, incubators, ventilators, and other equipment. Because of the flexible nature of the materials, the device will contour the surface where is placed on making the size of the user unimportant Lastly, FIG. 6 shows the device converted to the pediatric bolster support system device holding an external object, this case a pacifier. It is tied and secured by the string (Part 3 b) at the end of the extension (part 5). Also, to convert into the pediatric bolster support system device, the string at the cuff (Part 3 a) secures the pellets in the extension side (part 5) of the device to increase the volume and make it less flexible to be able to support the pacifier. As other options, the “fingers” of Part 1 and the string at the cuff (Part 3 a) may also be used to assist with positioning/securing of items. The device may also be used as a weight, near or away from the infant, to keep blankets, toys, and/or other devices such as medical equipment in place (i.e., tubes, IVs, ventilators, monitor and other cables, etc).

[0057] It is explicitly stated that the claimed device is not limited to the explanation of the chosen alternatives but encompasses other modifications/alterations within the scope of this ingenious concept. 

I claim:
 1. A flexible device with a cavity of a shape of a human hand (glove or mitten), that provides comfort, support, positioning aid and sense of security to infants, especially those born prematurely. This cavity has a predetermined fill density to allow flexibility and contour of the body of the infant. The material of the filling is high-density polymer pellets and the cavity's is a soft, washable material that may be in contact with the skin of the infant.
 2. A comfort, positioning aid, support and sense of security device as defined in claim 1 wherein the composition of said pellets is high density polyethylene (HDPE)
 3. A comfort, positioning aid, support and sense of security device as defined in claim 1 wherein the material of the cavity is a soft, smooth, washable material such as 100% cotton or 100% polyester fabric.
 4. A comfort, positioning aid, support and sense of security device as defined in claim 1 wherein the fill density of pellets comprises 60 to 80% of the total cavity.
 5. A comfort, positioning aid, support and sense of security device as defined in claim 1 wherein the weight of the pellets may range from 100-300 grams.
 6. A comfort, positioning aid, support and sense of security device as defined in claim 2 where said pellets are spherical in shape and about 1 to 3 mm in diameter.
 7. An optional extension to the device as defined in claim 1 that increases the length of the cuff by 25-30 cms to mimic a forearm/arm or sleeve. This extension increases the volume and weight of the device keeping the same fill density of claim 4 and increasing the weight of claim
 5. This sleeve potentially converts into a pediatric bolster support system device.
 8. An optional tying mechanism added to the device as defined in claim 1 where said tying mechanism is a string at the cuff and at the end of the “extension” as defined in claim
 7. These strings of 25-30 cms of length are placed to secure external items, to store the device by hanging it, or to secure the pellets (as defined in claim 4) in either side of the device (the hand and the extension) to modify the volume density of both sides. 